Measurement of Feeding Experience for Infants With Non-Oral Feedings

SPECIFIC AIMS: Feeding that circumvents the oral cavity drastically alters the infant's
feeding experience and may lead to oral feeding difficulty. It is estimated that 35 - 40% of
infants exhibit oral feeding difficulty and 34% of infants evaluated for oral feeding
difficulty develop oral feeding resistance during the first year of life. Behaviors
associated with oral feeding difficulty include: unclear infant behaviors signaling hunger
or satiation; the infant frequently interrupts the feeding, spitting or vomiting, or
postural changes during the feeding; infant irritability; increased or decreased length of
feeding; delayed acquisition of feeding skills, and disengagement during feeding. Oral
feeding resistance is more severe and includes persistent food refusal >1 month, disruptive
mealtime behavior, rigid food preferences, gagging in anticipation of feeding, and/or
vomiting and failure to master feeding skills consistent with the child's developmental
level. The consequences of oral feeding difficulty involve: delayed oral feeding, growth
failure, delayed perceptual motor performance, and disengagement with the caregiver related
to feeding, which leads to less optimal patterns of parent-infant interaction. It is
currently unknown what the early indicators of oral feeding difficulty are or when they
begin to develop. The purpose of this research is to prospectively describe early feeding
and social interactive behaviors of tube fed infants prior to the later development of oral
feeding difficulty and retrospectively compare differences in these behaviors in infants who
exhibit oral feeding difficulty with infants not exhibiting these behaviors.

Throughout the first year of life, infant growth, parent perception of infant feeding,
clinician assessment of infant feeding skills, and infant and maternal behavior during
feeding will be evaluated to document the occurrence of oral feeding difficulty, allowing
for a comparison of these early in hospital feeding behaviors. The study aims are to:

Aim 1: Describe the range of early feeding behaviors (pre-feeding, intra feeding, and post)
and feeding progression in hospitalized infants who have long term exposure to naso-gastric,
oral-gastric and gastrostomy tube feedings. Feeding behaviors are measured as behavioral
states, orally directed behaviors, social interactive behaviors (engagement and
disengagement behaviors), hunger and satiation cues, sucking organization, and motor
activity. Feeding progression is measured as the daily change in the proportion of tube to
oral intake.

Aim 2: Identify the change in early feeding behaviors throughout the infant's hospital stay.

Aim 3: Compare the early feeding behaviors of infants with and without oral feeding
difficulty at 12 months corrected age (CA).

Aim 4: Compare parent perception and provider assessment of feeding, maternal sensitivity to
infant, response to distress, social-emotional and cognitive growth foster cues and infant
clarity of cues and responsivity to mother during feeding at hospital discharge and 2, 4, 6,
and 12 months CA for infants with and without oral feeding difficulty at 12 months CA.

BACKGROUND AND SIGNIFICANCE: While most healthy infants establish the recurring cycle of
hunger, oral feeding, and satiation in association with transition of behavioral states,
orally directed behaviors, and social interaction, hospitalized infants often experience
tube or intravenous feeding for extended periods of time, which contributes to
non-establishment of hunger, feeding, and satiation patterns. Unlike normal healthy infants
who experience the pleasurable sensations of smell, taste, touch, and social interaction
associated with oral feeding, hospitalized infants often have aversive oral experiences
related to intubation, insertion of oral gastric tubes, and suctioning. Behaviors associated
with oral feeding difficulty include: unclear infant behaviors signaling hunger or
satiation; the infant frequently interrupts the feeding, frequent interruptions, spitting or
vomiting, or postural changes during the feeding; infant irritability; increased or
decreased length of feeding; delayed acquisition of feeding skills, and behavioral
disengagement during feeding. Oral feeding resistance is more severe and may include but is
not limited to food refusal, disruptive mealtime behavior, rigid food preferences, increased
or decreased length of feeding, altered patterns of mother-infant interaction, suboptimal
growth, and failure to master feeding skills consistent with the child's developmental
level. The consequences include: delayed oral feeding, and disengagement with the caregiver
related to feeding (which leads to parent/caregiver frustration.

The cost of tube feeding averages $40,000 during the first year of life. The cost of
outpatient behavioral treatment ranges from $10,000 to $52,000 and readmission treatment
averages $ 330,000.

Infant Characteristics and Behaviors Related to Feeding and Oral Feeding Difficulty: The
feeding experience encompasses the infant's preparation for feeding (prefeeding period), as
well as the actual feeding (intra feeding) and post feeding periods. Feeding involves
complex anatomic structures, coordination of breathing, sucking and swallowing, reflex
activity, a constellation of behaviors, and social interaction. Several infant
characteristics including gestational age (GA), post menstrual age, birth weight, health
status, and long term tube feeding have been shown to influence oral feeding.

There is a paucity of research that identifies the constellation of behaviors prior to,
during and post feeding for infants during tube feedings. Additionally, interventions
currently in use for hospitalized infants experiencing feeding difficulties predominately
address the intra feeding period. Management of oral feeding difficulty for older
infants/children is intensive, yet also addresses the intra feeding period.

Oral Feeding Progression: Low level oral feeding skills and slow feeding progression are key
indicators of oral feeding difficulty. Lau and Smith categorized levels of oral feeding
skill that include fatigue and endurance. Infants with more alert behavioral states
progressed more quickly to complete oral feedings.

Importance of Mother-Infant Interaction: Feeding holds the central opportunity for the
development of long lasting patterns of mother infant interaction. Feeding is critically
important because it involves mother-infant interaction; is a primary factor that affects
growth; and is a major concern for both clinicians and parents during the transition to full
oral feeding and through discharge to home. When the infant is unable able to engage with
the mother during feedings, this difficulty leads to non-optimal mother-infant interaction
and the potential for altered infant development.

Oral Feeding Difficulty: Oral feeding difficulty is identified by both parents and
clinicians. Parent perception offers detailed information from the parent's perspective and
includes ease/difficulty of feeding the infant, the infant's behavioral cues surrounding the
feeding experience, how the parent sets up and begins the feedings, and the length of
feeding. Clinician assessment identifies the infant's oral feeding skills.

Design and Methods Prospective design. Infant feeding behavior, feeding progression, and
growth will be evaluated weekly during hospital stay. Parent perception and clinician
assessment of oral feeding difficulty will be evaluated at 2, 4, 6, and 12 months corrected
age. Mother-infant interaction will be evaluated at hospital discharge and throughout the
first year of life.

Sample: We will enroll 75 infants from Children's Hospital of Wisconsin (CHW) who are
expected to receive a minimum of two weeks of non-oral formula/breast milk feedings during
hospitalization. Infants meeting the following criteria will be eligible for this study:
prior surgical treatment for gut, or chest surgery (non cardiac), or non-surgical infants
who will require a minimum of two weeks of non-oral formula/breast milk feedings. Infants
may be receiving oxygen therapy and intravenous therapy. Infants may have previously been
treated for sepsis, pneumonia, received intravenous only intake, or managed with assisted
ventilation.

Exclusion criteria include those infants who are currently being treated for sepsis,
pneumonia, intravenous only intake, receiving assisted ventilation, have congenital
anomalies of the oral cavity, chromosomal abnormalities, or are not neurologically intact
(e.g. hypoxic ischemic encephalopathy or significant neurologic deficit).

Procedures Procedures for Data Collection. Evaluation data are collected at enrollment,
weekly during hospitalization, at hospital discharge, and at 2, 4, 6, and 12 months CA. At
enrollment, after informed consent is obtained, the in-hospital research nurse will conduct
the medical record review and obtain the infant demographics/risk factors.

The early feeding behaviors data will be obtained weekly. Infants will be video recorded for
90 minutes. The first 30 minutes will comprise the pre feeding time. Immediately following
the 30 minute pre feeding recording, the infant will be fed (approximately 20 - 30 minutes
for the feeding). After the feeding is complete, the video recording will be continued for
an additional 30 minutes. The early feeding behaviors data are assessed during the entire 90
minute data collection session. Infants will remain on their cardiac monitors during the
session. The video recorded data will be transferred from the video camera to the secure
(encrypted) server and saved. The video recordings will also be downloaded into the Mangold
system for coding. The feeding progression data will be collected from the medical record.

Outcomes assessed at hospital discharge. Within 24 hours of discharge, the final assessment
of early feeding behaviors will occur. In addition, sucking organization will be measured
for infants who are partially or fully oral fed at discharge. The medical record will be
reviewed for the hospital progression data (feeding progression, type of feeding the infant
receives, weight gain, length, head circumference, length of hospital stay). The oral
feeding skills and sucking organization data will be collected by a member of the research
team. Mother-infant interaction will be assessed during a feeding.

Outcomes assessed after Infant Discharge at 2, 4, 6, and 12 months CA. Infant growth and
mother-Infant interaction during feeding and play will be assessed at 2, 4, 6, and 12 months
CA in the Pediatric Translational Research Unit. Difficulty with Oral Feeding during the
infant's first 12 months, will be identified through parent self report and clinician
assessment. Mother-infant interaction will be assessed during a feeding.

Statistical Analysis Plan: Frequencies and 95% confidence intervals based on the appropriate
model for the variation will be calculated for the behavioral data and changes in the
behavior over time. The behavioral data will be converted to percents, counts and rates over
time (weeks) to evaluate change over time (maturation). Changes over time will be modeled as
linear, curvilinear or step functions with fractional polynomials. Analysis of changes over
time will use Generalized Linear Mixed Models (GLMM) for repeated count (Poisson) and
frequency/categorical (logistic and multinomial logistic). Where the outcome occurs only
once, such as feeding by tube at discharge, the corresponding Generalized Linear Model (GLM)
will be used for regression modeling; e.g. a Poisson GLM instead of Poisson GLMM, a logistic
GLM in place of a logistic GLMM, etc. (AIM 1 and AIM 3).

Infant Inclusion Criteria: * prior surgical treatment for gut,

- chest surgery (non cardiac),

- or non-surgical infants who will require a minimum of 2 weeks of non-oral
formula/breast milk feedings,

- may be receiving oxygen therapy and intravenous therapy.

- may have previously been treated for sepsis, pneumonia, received intravenous only
intake, or managed with assisted ventilation. Maternal Inclusion criteria: *must be
able to read and comprehend English. Infant Exclusion Criteria: *infant receiving
assisted ventilation,